NCT02515604

Brief Summary

A randomised controlled trial assessing the efficacy of single versus repeated dose of vaginal misoprostol for the treatment of early pregnancy failure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 2, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 5, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

11 months

First QC Date

August 2, 2015

Last Update Submit

October 31, 2016

Conditions

Abortion, Missed

Outcome Measures

Primary Outcomes (1)

  • Complete abortion (Endometrial thickness of less than 15 mm, as assessed by trans-vaginal ultrasound.)

    Endometrial thickness of less than 15 mm, as assessed by trans-vaginal ultrasound.

    Day 8 from first misoprostol dose

Study Arms (2)

Single dose group

ACTIVE COMPARATOR
Drug: Misoprostol

Repeated dose group

ACTIVE COMPARATOR
Drug: Misoprostol

Interventions

MisoprostolDRUG
Also known as: Cytotec
Repeated dose groupSingle dose group

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with early pregnancy failure, defined as missed abortion or blighted ovum, seeking medical treatment with misoprostol.
  • Age equal or greater than 18 years
  • Gestational age less than 12 complete weeks.

You may not qualify if:

  • Complete, incomplete, inevitable, or septic abortion.
  • Hemodynamically unstable patients.
  • Misoprostol sensitivity or contraindication.
  • Multifetal pregnancies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wolfson Medical Center

Holon, Israel

Location

Related Publications (1)

  • Mizrachi Y, Dekalo A, Gluck O, Miremberg H, Dafna L, Feldstein O, Weiner E, Bar J, Sagiv R. Single versus repeat doses of misoprostol for treatment of early pregnancy loss-a randomized clinical trial. Hum Reprod. 2017 Jun 1;32(6):1202-1207. doi: 10.1093/humrep/dex074.

    PMID: 28402415DERIVED

MeSH Terms

Conditions

Abortion, Missed

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Yossi Mizrachi, MD

    Wolfson Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 2, 2015

First Posted

August 5, 2015

Study Start

August 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations

IL(1)